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What Is the Best Approach to Reducing Birth Defects Associated with Isotretinoin?

  • Lorien Abroms,
  • Edward Maibach,
  • Katherine Lyon-Daniel,
  • Steven R Feldman
  • Published: November 21, 2006
  • DOI: 10.1371/journal.pmed.0030483

Reader Comments (1)

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Response to Steven Feldman

Posted by plosmedicine on 31 Mar 2009 at 00:02 GMT

Author: Lorien Abroms
Position: See original article for full affiliations
Institution: See original article for full affiliations
E-mail: sphlca@gwumc.edu
Additional Authors: Ed Maibach and Katherine Lyon-Daniel
Submitted Date: November 22, 2006
Published Date: November 22, 2006
This comment was originally posted as a “Reader Response” on the publication date indicated above. All Reader Responses are now available as comments.

To the Editors:

We agree completely with Dr. Feldman that risk management programs should be designed with the needs of users in mind, and should be pre-tested before full implementation. Indeed, this was one of the central points we attempted to make in our article.

We disagree, however, that aggressive risk management programs such as iPLEDGE needlessly constrain clinicians' ability to serve their patients. A recent news story in Dermatology Times nicely illustrates this point [1]. The story pointed out that while dermatologists did initially encounter difficulty using iPLEDGE, these problems have now largely been ironed out, and dermatologists are now accruing some benefits from the system such as reduced liability.

We also take issue with Dr. Feldman's assertion that the overall benefits of isotretinoin outweigh the risks. The benefit of reducing acne for a large number of patients may not, in fact, outweigh the risks of death or permanent life-long disability to a baby born from an exposed pregnancy [2-4]. Admittedly, it is difficult to decide whether to favor people with common but mild conditions or those with rarer but potentially fatal conditions.

Fortunately, because of iPLEDGE, we may not need to decide. If iPLEDGE is found to be effective, in its current form or with additional improvements, we will be able to give patients with acne access to a treatment which can improve their quality of life, while significantly reducing the number of fetuses exposed to isotretinoin.

Lorien Abroms
Ed Maibach
Katherine Lyon-Daniel

1. Melville, NA. iPledge offers benefits some may not have considered. Dermatology Times. August 1, 2006. Available at : www.dermatologytimes.com/. Accessed September 20, 2006.
2. Food and Drug Administration (FDA). Dermatologic Drugs Advisory Committee. October 21, 1983. Available at: http://www.fda.gov/ohrms/.... Accessed on September 20, 2006.
3. Food and Drug Administration (FDA). Dermatologic Drugs Advisory Committee. April 26, 1988. Available at: http://www.fda.gov/ohrms/.... Accessed on September 20, 2006.
4. Food and Drug Administration (FDA). Dermatologic Drugs Advisory Committee. April 26, 1988. Available at: http://www.fda.gov/ohrms/.... Accessed on September 20, 2006.

No competing interests declared.